Overview

This trial is active, not recruiting.

Conditions acquired immunodeficiency syndrome, hiv infections
Treatments stribild, rtv, tvd, pi
Phase phase 3
Sponsor Gilead Sciences
Start date November 2011
End date November 2013
Trial size 420 participants
Trial identifier NCT01475838, 2011-004483-30, GS-US-236-0115

Summary

This study will evaluate the non-inferiority of stribild (elvitegravir/cobicistat/ emtricitabine/tenofovir disoproxil fumarate [EVG/COBI/FTC/TDF]) single-tablet regimen relative to regimens consisting of a ritonavir-boosted protease inhibitor (PI/r) plus truvada (FTC/TDF) fixed-dose combination in maintaining HIV-1 RNA < 50 copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of treatment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Participants will be randomized to switch to the Stribild® for 96 weeks.
stribild
Elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg single-tablet regimen (STR) administered orally once daily with food
(Active Comparator)
Participants will be randomized to remain on their current antiretroviral regimen consisting of an RTV-boosted PI plus TVD for 96 weeks.
rtv
Ritonavir (RTV) administered according to prescribing information
tvd Truvada®
Truvada (TVD) administered according to prescribing information
pi
Protease inhibitors (PI) administered according to prescribing information, which may include atazanavir (ATV), darunavir (DRV), fosamprenavir (FPV), lopinavir (LPV), or saquinavir (SQV).

Primary Outcomes

Measure
Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 48 as defined by the FDA snapshot analysis
time frame: Week 48

Secondary Outcomes

Measure
Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 96 as defined by the FDA snapshot analysis
time frame: Week 96
Change from baseline in CD4+ cell count at Weeks 48 and 96
time frame: Weeks 48 and 96

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Ability to understand and sign a written informed consent form - Be on a stable antiretroviral regimen consisting of a ritonavir boosted PI plus FTC/TDF continuously for ≥ 6 consecutive months preceding the screening visit - Be on the first or second antiretroviral drug regimen documented undetectable plasma HIV 1 RNA levels for ≥ 6 months preceding the screening visit - No previous use of any approved or experimental integrase strand transfer inhibitor (INSTI) for any length of time - Documented historical genotype prior to starting initial antiretroviral therapy showing no known resistance to TDF or FTC - HIV RNA < 50 copies/mL - Normal ECG - Hepatic transaminases ≤ 5 × upper limit of normal (ULN) - Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin - Adequate hematologic function - Serum amylase ≤ 5 × ULN - Estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft-Gault (C-G) formula - Females of childbearing potential must agree to utilize highly effective contraception methods, or be non-heterosexually active, practice sexual abstinence from screening throughout the duration of the study period and for 30 days following the last dose of study drug - Female subjects who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing - Male subjects must agree to utilize a highly effective method of contraception during heterosexual intercourse from the screening visit, throughout the duration of the study and for 30 days following discontinuation of investigational medicinal product, or must be non-heterosexually active, or practice sexual abstinence - Age ≥ 18 years Exclusion Criteria: - A new AIDS-defining condition diagnosed within the 30 days prior to screening - Females who are breastfeeding - Positive serum pregnancy test (female of childbearing potential) - Receiving drug treatment for Hepatitis C, or subjects who are anticipated to receive treatment for Hepatitis C during the course of the study - Experiencing decompensated cirrhosis - Have an implanted defibrillator or pacemaker - Current alcohol or substance abuse that would interfere with compliance - A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma - Active, serious infections requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline, except for intramuscular penicillin for the treatment of syphilis - Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study - Subjects receiving ongoing therapy with any of the medications, including drugs not to be used with EVG, COBI, FTC, TDF or subjects with any known allergies to the excipients of EVG/COBI/FTC/TDF tablets, or Truvada® tablets. - No anticipated need to initiate drugs during the study that are contraindicated - Receiving other investigational drugs - Participation in any other clinical trial - Any other clinical condition or prior therapy that would make the subject unsuitable for the study or unable to comply with the dosing requirements

Additional Information

Official title A Phase 3b Randomized, Open Label Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI/r) Plus Emtricitabine/Tenofovir Fixed-Dose Combination (FTC/TDF) to the Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically Suppressed, HIV 1 Infected Patients
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Gilead Sciences.